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Completed

NCT Number: NCT02733705

Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer. This procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. So, this study is to find out whether opioids is need for TRUS biopsy.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Sirilak Suksompong

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 year
  • Patient American society of anesthesiology physical status I-III.
  • Scheduled for Transrectal ultrasound-guided prostate biopsy
  • BMI equal to or less than 30 kg/cm2

Exclusion criteria

  • Known hypersensitivity to propofol or fentanyl
  • History of bleeding tendency
  • Known case of active anal or rectal disease
  • Unable to rate pain score
  • History of drug abuse
  • Chronic opioid use

Treatment and study plan

Control

Other

normal saline IV

Fentanyl

Drug

fentanyl 0.5 mcg/kg ideal BW

Propofol

Drug

propofol infusion

Primary outcomes

  1. Pain assess using Numeric rating scale (NRS) score

    Time frame: 20 minutes

Secondary outcomes

  1. Number of participants with hypoxia defined as oxygen saturation <92%

    Time frame: 60 minutes

    The investigators define hypoxia as oxygen saturation < 92%. The investigators will report as number of episode.

  2. Number of participants with hypotension, defined as systolic blood pressure <90 mmHg

    Time frame: 60 minutes

    The investigators define hypotension as systolic blood pressure< 90 mmHg. The investigators will report as number of episode.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A Randomised Controlled Trial Comparing Combined Intravenous Propofol and Fentanyl Versus Intravenous Propofol Alone for Sedation in Patients Undergoing Transrectal Ultrasound-guided (TRUS) Prostate Biopsy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2016
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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